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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K032170
Device Name TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
Applicant
Medical Industries America, Inc.
2636 289th Place
Adel,  IA  50003 -8021
Applicant Contact ANNE B CARLSON
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED E DEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/16/2003
Decision Date 05/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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